FDA 510(k) Application Details - K182875

Device Classification Name	More FDA Info for this Device
510(K) Number	K182875
Device Name	DeepCT
Applicant	Deep01 Limited Rm. 5, 11F., No.162, Sec. 4, Roosevelt Rd. Taipei City 10091 TW Other 510(k) Applications for this Company
Contact	William Lai Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/12/2018
Decision Date	07/10/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review